Kornimate/medical-research-clean huggingface dataset:
maternal determinants of hiv-exposed and hiv-unexposed fetal growth, birth outcomes and early infant growth

Conditions: HIV; Pregnancy; Malnutrition; Cachexia

Summary: the purpose of this study is to understand how differences in the nutritional status and concentration of hormones and cytokines associated with cachexia in hiv+ and hiv- pregnant women living in a semi-rural and rural region of northern tanzania affect fetal growth, pregnancy outcomes and early infant health and development. the study hypothesis is that hiv+ women will have worse nutritional status and a greater degree of cachexia which will negatively impact fetal growth, pregnancy outcomes and early infancy health and development.


Eligibility criteria:
inclusion criteria: * informed consent provided by mothers, and parental consent on behalf of their infants * confirmed hiv status (hiv-1, hiv-2 or hiv-dual seropositive or hiv-seronegative) * estimated gestational age between 12th and 34th weeks * stated intention to remain in the clinic catchment area ≥6 months post-partum * singleton birth exclusion criteria: * none
a study to assess the safety and effectiveness of the uroactive® artificial urinary sphincter (aus)

Conditions: Stress Urinary Incontinence (SUI)

Summary: prospective, multicenter, single-arm study


Eligibility criteria:
key inclusion criteria: * male subjects aged ≥ 22 years old * able to read, comprehend and willing to sign an informed consent form * primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator * appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator key exclusion criteria: * currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent * poor candidate for surgical procedures and/or anesthesia, as determined by investigator * currently implanted with an active implantable medical device (aimd) * symptoms or diagnosis of urge incontinence or mixed incontinence (mi) with a predominant urgency component, as assessed by the investigator

Keywords: stress urinary incontinence artificial urinary sphincters
comparative performance of 64copper [64cu]-sar-bis-psma vs 68ga psma-11 pet ct for the detection of prostate cancer recurrence in the setting of biochemical failure following radical prostatectomy

Conditions: Prostate Cancer (Post Prostatectomy)

Summary: the goal of this clinical trial is to compare 64cu-sar-bispsma pet/ct and 68ga psma-11 pet/ct in men with biochemical failure following radical prostatectomy. the main questions it aims to answer are: * is there a difference in the number of lesions of prostate cancer recurrence detected between the 64cu-sar-bispsma pet/ct and 68ga psma-11 pet/ct scans. * what is the diagnostic accuracy of 64cu-sar-bispsma pet/ct compared to 68ga psma-11 pet/ct using a standard of care comparator. * evaluate the magnitude of clinical management change when using 64cu-sar-bispsma additional to standard of care imaging (68ga psma-11). participants will: * have 3 visits: 1) standard of care 68ga psma-11 dose and pet/ct scan; 2) 64cu-sar-bispsma dose and pet/ct; 3) 64cu-sar-bispsma pet/ct only * have standard of care blood test either at visit 1 or visit 2


Eligibility criteria:
inclusion criteria: * male patients aged 18 or above * ability to provide informed consent documentation indicating that they understand the purpose of, and procedures required for the study, and are willing to participate in the study. * prior radical prostatectomy for confirmed adenocarcinoma on histopathology. * rising psa (0.20 - 0.75 ng/ml) following radical prostatectomy with no prior salvage radiotherapy. * 68ga psma-11 pet/ct within the last 4 weeks for prostate cancer biochemical recurrence. exclusion criteria: * prior, or contraindication to, salvage radiotherapy for biochemically recurrent prostate cancer. * history of current active malignancy as per investigator discretion other than prostate cancer. * known or expected hypersensitivity to 64cu-sar-bispsma * systemic therapy for metastatic prostate cancer including androgen deprivation therapy.

Keywords: prostate cancer salvage radiotherapy prostatectomy co-psma clp11 prostate cancer recurrence biochemical failure radical prostatectomy copper pet scan
a phase ii study to evaluate the effects of oral ono-5129 in type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ono-5129 in patients with type 2 diabetes mellitus


Eligibility criteria:
inclusion criteria: 1. type 2 diabetes mellitus 2. fbg level \> 140 mg/dl and \< 270 mg/dl 3. fasting tg level \< 500 mg/dl 4. bmi of 22 to 40 kg/m2, inclusive 5. other inclusion criteria as specified in the study protocol exclusion criteria: 1. previous participation in an ono-5129 protocol 2. previous treatment with tzd agents or other current antidiabetics 3. history of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months 4. presence of functional limitations due to cardiovascular disease in accordance with the new york heart association classification system - class iii (moderate) or iv (severe) 5. other exclusion criteria as specified in the study protocol
a study to assess the long-term safety and efficacy of a subcutaneous formulation of efgartigimod in adults with active idiopathic inflammatory myopathy

Conditions: Myositis; Active Idiopathic Inflammatory Myopathy; Dermatomyositis; Polymyositis; Immune-Mediated Necrotizing Myopathy; Antisynthetase Syndrome

Summary: the purpose of this study is to measure the long-term safety and tolerability of efgartigimod ph20 sc in adult participants with iim who previously participated in argx-113-2007. secondary objectives include efficacy measures of efgartigimod ph20 sc in participants with iim.


Eligibility criteria:
inclusion criteria: * has completed trial argx-113-2007 * being capable of providing signed informed consent and complying with protocol requirements * agrees to use contraceptive measures consistent with local regulations and women of childbearing potential must have a negative urine pregnancy test at baseline before receiving the investigational medicinal product exclusion criteria: * intention to have major surgery during the study period; or any other medical condition that has arisen since enrollment in study argx-113-2007, that in the investigator's opinion, would confound the results of the study or put the participant at undue risk * known hypersensitivity reaction to investigational medicinal product or 1 of its excipients development of any malignancy, either new or recurrent, other than basal cell carcinoma of the skin, regardless of relatedness * permanent discontinuation of imp in argx-113-2007, or met the permanent discontinuation criteria at the rollover visit * diagnosis with a deselected subtype of myositis based on the analysis of the phase 2 stage data in argx-113-2007, unless the investigator determines that the participant is benefiting from imp as defined by a score of "much better" or "moderately better" on the 'clinical global impression of change' and 'patient global * impression of change' assessments for at least 12 weeks, and that enrolling in the study is in the participant's best interest
use of very low calorie diet preoperatively to bariatric surgery

Conditions: Bariatric Surgery Candidate; Very Low Calorie Diet; Weight Loss

Summary: to investigate use of very low calorie diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

in this project the investigators want to develop an effective very low calorie diet (vlcd) treatment prior to bariatric surgery, which is optimized in relation to the size and speed of the weight loss as well as in terms of satisfaction both for the patients as for the health care professionals. thus the investigators will randomize 500 patients to either vlcd or standard care prior to bariatric surgery. the investigators aim to optimize preoperative and the operative course for patients, who are offered bariatric surgery.

Eligibility criteria:
inclusion criteria: * eligible for bariatric surgery exclusion criteria: -
resilience to sleep deprivation and changes in sleep architecture in shoonya meditators

Conditions: Sleep; Sleep Deprivation; Cognitive Change

Summary: this study aims to investigate the effect of a 15-minute meditation practice on sleep architecture and high-frequency heart rate variability (hf-hrv), as well as cognitive performance after both a well-rested and sleep-deprived night.

sleep is physiologically important for memory consolidation, mood and hormonal regulation, and maintaining low levels of systemic inflammation. however, a substantial proportion of people are reported to regularly sleep less than the recommended 7-9 hours a night. meditation may be a means to mitigate the negative effects of sleep deprivation, as many types of meditations are associated with increasing high-frequency heart rate variability (hf-hrv), which is an index of parasympathetic control of the heart. greater parasympathetic drive may be associated with physiological buffering of the detrimental effects of sleep deprivation. the investigators want to conduct a prospective cohort study where subjects are asked to learn and practice a 15-minute meditation (shoonya meditation) or continue their usual routine. subjects will be asked to complete some cognitive tests before and after a night of sleep and a night of sleep deprivation. during the night of sleep, participants will undergo polysomnography recording for sleep architecture and quality. the intervention group will be asked to undergo these same study procedures after 2 months of meditation practice. the control group, which continues their usual routine, will only undergo one visit.

Eligibility criteria:
inclusion criteria: 1. shoonya meditation program participants/individuals eligible to participate who are healthy adults of age 18 or older, and reside in the united states. participants must be able and willing to travel to boston. 2. nap group: healthy adults of age 18 or older that reside in the united states, nap regularly (at least 3 times a week), and do not meditate regularly. exclusion criteria: 1. history of any neurological condition (i.e. parkinson's disease, alzheimer's disease, huntington's disease, brain tumors, brain surgery, or multiple sclerosis) 2. history of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder) 3. current use of cognition enhancing medications 4. active history (within the last 5 years) of alcohol or drug abuse (\> 10 drinks per week) 5. history (within the last 5 years) of stroke/aneurysm 6. recent history (\< 3 months) of seizures 7. 60 years of age or older 8. history of heart attack and ejection fraction less than or equal to 30% 9. pregnancy 10. non-english speaking 11. history/diagnosis of any sleep disorder 12. consumption of 3 or more cups of coffee a day 13. previously learned shoonya meditation (for the meditator groups)

Keywords: sleep sleep disorder sleep deprivation meditation shoonya meditation
gamma-amino butyric acid (gaba)-a alpha2/3 study

Conditions: Schizophrenia

Summary: the purpose of this research study is to determine whether a short-term administration of an investigational study drug may provide evidence of improvement in cognitive functioning in a group of stable male subjects with schizophrenia.

the goal of this study is to determine whether the short-term (4 week), double-blind administration of merck l-830982 provides evidence of improvement in cognitive functioning in stable male subjects with schizophrenia. this initial, small sample size study (n=9 on l-830982 and n=6 on placebo) is restricted to males in order to reduce the variance that might be attributable to the well-documented sex differences in the clinical features of schizophrenia.

Eligibility criteria:
inclusion criteria: * male participants * between the ages of 18 and 50 * meet diagnostic criteria for schizophrenia or schizoaffective disorder * are clinically stable for a minimum of 3 months on current dose of medication * are unemployed (i.e., work less than 20 hours per week at competitive employment) exclusion criteria: * psychoactive substance dependence within the past 6 months or substance abuse within the past month * history of head trauma or other neurological disorder * medical illness or medications, such as benzodiazepine treatment or hiv medications, that may be affected by study participation (the study doctor will discuss this with potential subjects) * mental retardation * seizure disorder * history of a heart attack, arrhythmia, or other heart disease

Keywords: schizophrenia
validation of predictors of oac initiation using emr data

Conditions: Atrial Fibrillation

Summary: the objectives of this study are, first, to identify select clinical covariates from electronic medical records (emr) that might be associated with initiation of oral anticoagulant medications (dabigatran or warfarin) in patients with non-valvular atrial fibrillation (nvaf) at risk for stroke; second, to quantify the association between emr-based clinical characteristics and patterns of insurance claims; third, to assess the potential for unmeasured confounding in dabigatran vs warfarin comparative effectiveness and safety studies based on administrative claims databases.


Eligibility criteria:
inclusion criteria: * first dispensing of warfarin or dabigatran between october 2010 and december 2014 * diagnosis of atrial fibrillation * ≥ 12 months enrolment in the database preceding the date of the first dispensing * age ≥ 18 * congestive heart failure, hypertension, age \> 75, diabetes mellitus, prior stroke or transient ischemic attack, vascular disease (cha2ds2-vasc) score ≥ 1 exclusion criteria: * prior use of oral anticoagulation * evidence of valvular atrial fibrillation * missing or ambiguous age or sex information * patients with a nursing home stay during baseline
oral intake during labor

Conditions: Labor Complication; Food Aspiration; Complication of Anesthesia; Satisfaction

Summary: a randomized clinical trial (rct) to evaluate the impact of unrestricted low fat, low residue oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.

this study is a quantitative, randomized experimental design study to determine the impact of unrestricted low fat, low residue oral intake during labor on the indicated outcome variables and patient satisfaction. the comparison group will continue standard care of being allowed a clear liquid during active labor (≥6cm dilation), while the experimental group would be allowed to self-regulate oral intake with a low fat, low residue diet during active labor.

Eligibility criteria:
inclusion criteria: * active duty and department of defense (dod) beneficiary pregnant women 18 years of age and older * 37 weeks gestation or greater at time of admission * singleton fetus * cephalic presentation * who plan to labor/deliver at dgmc (military beneficiaries). exclusion criteria: * morbid/severe obesity (pre-pregnancy bmi ≥40 kg/m2 * diabetes * hypertension (to include pre-eclampsia or eclampsia) * previous cesarean section * uncontrolled gastroesophageal reflux disease (gerd) (symptomatic with medication) * past history or current diagnosis of hyperemesis gravidarum * food allergies to any items contained in the gastric/soft bland diet * patients utilizing nitrous oxide for labor analgesia (should this treatment be available at dgmc) * difficult airway as defined by the anesthesia staff. * mallampati score 3 or 4 * thyroid mental distance less than 7 cm or 3 finger breaths * mouth opening less than 3 finger breaths * short thick neck, micrognathia * further indications as determined by the anesthesia provider doing the anesthesia preoperative assessment (pregnancy in and of itself will not be considered a disqualification due to airway changes during labor)" in order to define difficult airway per anesthesia. * under age 18 * additional clinical risk factors as determined by the care provider

Keywords: labor anesthesia oral intake maternal satisfaction newborn complications
manual therapy in postoperative breast cancer

Conditions: Breast Cancer; Axillary Lymph Node Dissection; Shoulder Joint Limitation

Summary: to evaluate the effectiveness of manual therapy (joint mobilization and massage) combined with kinesiotherapy in women with impaired range of motion after axillary lymph node dissection due to breast cancer regarding the recovery of shoulder range of motion and functionality of the upper limb.


Eligibility criteria:
inclusion criteria: * surgery of breast cancer at university of campinas * axillary lymph node dissection * injury of shoulder range of motion exclusion criteria: * bilateral surgery * previous radiotherapy * bone metastasis in homolateral upper limb * axillary web syndrome
improving pain management and decreasing los after total hip arthroplasty (tha) and total knee arthroplasty (tka)

Conditions: Pain

Summary: this two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay when comparing standard of care pain management with and without sufentanil.

this two arm, patient blinded, randomized, post market clinical trial in a single orthopedic hospital will determine whether there is improved pain management and decreased length of stay (los) when comparing standard of care pain management with and without sufentanil. the objective is to compare los between patients who have had primary tha or tka and have received standard of care peri-operative pain management and one dose of sufentanil 30 mcg sublingual pre-operatively in the operating room and one dose post-operatively in the post anesthesia care unit (pacu) versus those who have received only standard of care peri-operative pain management in a orthopedic specialty hospital.

Eligibility criteria:
inclusion criteria: 1. adults 50 to 80 years, inclusive 2. planned primary tha or tka 3. expressed willingness to be discharged the same day of surgery if condition allows 4. american society of anesthesiologists (asa) physical classes i - iii 1. asa i: a normal healthy patient. example: fit, nonobese (bmi under 30), a nonsmoking patient with good exercise tolerance. 2. asa ii: a patient with a mild systemic disease. example: patient with no functional limitations and a well-controlled disease (e.g., treated hypertension, obesity with bmi under 35, frequent social drinker or is a cigarette smoker). 3. asa iii: a patient with a severe systemic disease that is not life-threatening. example: patient with some functional limitation as a result of disease (e.g., poorly treated hypertension or diabetes, morbid obesity, chronic renal failure, a bronchospastic disease with intermittent exacerbation, stable angina, implanted pacemaker). 5. patients who are english competent. exclusion criteria: 1. opioid tolerant (\> 50 mg oral morphine milligram equivalents (mmes) daily) 2. current iv drug abuse 3. history of alcoholism 4. history of severe renal impairment 5. history of severe hepatic impairment 6. dependent on supplemental oxygen at home 7. pregnant 8. incarcerated 9. patient unable to provide informed consent 10. patients undergoing bilateral tka, tha 11. patient undergoing unicompartmental knee arthroplasty (uka) 12. patients undergoing other concurrent surgery 13. patients with a history of allergy to any drugs in the study.

Keywords: pain length of stay peri-operative tha tka
hardware removal after orif of ankle fractures

Conditions: Ankle Fractures

Summary: ankle fractures account for 10 % of fractures in the adult population. a part of patients (40%) is treated surgically. after healing of the fractures, about one year after the operation, a surgery is often performed to remove the hardware in order to diminish pain. if this surgery is necessary is debated in the literature. the aim of our study is to evaluate the outcome of hardware removal surgery after a surgery of the ankle for a fracture. for that, we will perform do a controlled randomized trial with two arms: one arm includes the participants who will have a hardware removal and the other arm will not have a surgery. outcome parameters are the patients reported outcome and pain related disability. they will be assessed by the questionnaires faam score (foot and ankle ability measure) and pdi (pain disability index) at the beginning and at the end of the study, at six months. the third outcome parameter will be the complication rate after an anklehardware removal surgery, which will be assessed through the ernst-ssink classification.

the study consists of a prospective multicentric parallel two-arm randomised non-blinded study, conducted at the hfr and rhne (level of evidence ii). the planned intervention is the following: after an orif of the ankle, patients have a follow-up. at the 12- month control, we ask eligible patients if they want to participate to the study. if they agree, they are randomised to treatment recommendations in one of two groups: conservative or surgical. the patients may follow or not the recommendations; not following the recommendations does not exclude them from the study. patients of both groups will fill out faam and pdi questionnaires at 12 and 18 months after the 1st operation. patients in the surgical group will have a hardware removal surgery. it is a very common operation consisting of hardware removal that is done ambulatory by the orthopaedic surgeons specialized in foot and ankle surgery. operated patients will have the usual postoperative follow-up (6 weeks, 3 months and 6 months postoperative) and all complications will be recorded and classified according to the ernst-sink classification

Eligibility criteria:
inclusion criteria: * \>18 y.o * operative treatment of ankle/foot fractures at hfr or rhne: * ankle fractures: bi-malleolar and tri-malleolar fractures or equivalent * faam score \>5%, \<95% * patient expected to complete length of study * patient with sufficient cognitive and linguistic ability in order to participate in the study. * operable patients (asa score ≤3) exclusion criteria: * absolute indications for hr: infection/malunion/allergy to metal/refracture * ankle fractures that are not listed in the criteria above * patient treated for a fracture at the same foot/ ankle before * patient with fracture of two different regions of the foot/ankle * patient treated for the fracture outside of hfr and rhne * patient non ambulating before time of injury * patients having diabete, * immunocompromised under chemotherapy, * peripheral artery disease stade iv * pregnant patients